VA and Duke University Medical Centers, Durham, NC 27705, USA.
J Clin Sleep Med. 2013 May 15;9(5):481-91. doi: 10.5664/jcsm.2672.
In recent years, polysomnography-based eligibility criteria have been increasingly used to identify candidates for insomnia research, and this has been particularly true of studies evaluating pharmacologic therapy for primary insomnia. However, the sensitivity and specificity of PSG for identifying individuals with insomnia is unknown, and there is no consensus on the criteria sets which should be used for participant selection. In the current study, an archival data set was used to test the sensitivity and specificity of PSG measures for identifying individuals with primary insomnia in both home and lab settings. We then evaluated the sensitivity and specificity of the eligibility criteria employed in a number of recent insomnia trials for identifying primary insomnia sufferers in our sample.
Archival data analysis.
Study participants' homes and a clinical sleep laboratory.
76 with primary insomnia and 78 non-complaining normal sleepers.
ROC and cross-tabs analyses were used to evaluate the sensitivity and specificity of PSG-derived total sleep time, latency to persistent sleep, wake after sleep onset, and sleep efficiency for discriminating adults with primary insomnia from normal sleepers. None of the individual criteria accurately discriminated PI from normal sleepers, and none of the criteria sets used in recent trials demonstrated acceptable sensitivity and specificity for identifying primary insomnia.
The use of quantitative PSG-based selection criteria in insomnia research may exclude many who meet current diagnostic criteria for an insomnia disorder.
近年来,基于多导睡眠图的入选标准越来越多地被用于确定失眠研究的候选人,这在评估原发性失眠的药物治疗的研究中尤其如此。然而,PSG 识别失眠患者的敏感性和特异性尚不清楚,也没有关于应用于参与者选择的标准集的共识。在本研究中,使用档案数据集来测试 PSG 测量在家庭和实验室环境中识别原发性失眠个体的敏感性和特异性。然后,我们评估了一些最近的失眠试验中使用的入选标准在识别我们样本中的原发性失眠患者的敏感性和特异性。
档案数据分析。
研究参与者的家庭和临床睡眠实验室。
76 名原发性失眠患者和 78 名无抱怨的正常睡眠者。
使用 ROC 和交叉表分析来评估 PSG 衍生的总睡眠时间、持续睡眠潜伏期、睡眠后觉醒和睡眠效率用于区分原发性失眠成人与正常睡眠者的敏感性和特异性。没有一个单一的标准能够准确地区分 PI 和正常睡眠者,而且最近试验中使用的标准集都没有表现出可接受的敏感性和特异性,无法识别原发性失眠。
在失眠研究中使用基于定量 PSG 的入选标准可能会排除许多符合当前失眠障碍诊断标准的人。